MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (b)(6) keeps shutting off was confirmed during the archive data review and functional testing.The root cause of the reported complaint was the defective processor to distribution board (pdb) cable, likely attributed to an aging device.The autopulse platform was manufactured in december 2007 and is16 years old, well beyond its expected service life of 5 years.Visual inspection showed a cracked front enclosure and some liquid under the lcd screen, unrelated to the reported complaint.The physical damage cover was likely attributed to mishandling such as a drop.The front enclosure was replaced to address the observed physical damage.The membrane switch assembly was replaced to remedy the observed liquid issue.During the archive data review, it showed the occurrences of the autopulse platform shut-off unexpectedly with two "battery lost" failures around the customer reported event date, thus confirming the customer's reported complaint.Also, the data archive was corrupted (showing the same date for all entries), unrelated to the reported complaint.The processor (pca) was replaced to remedy the fault.The autopulse platform was powered on and immediately powered off by itself during functional testing, thus confirming the customer reported complaint.The processor to distribution board (pdb) cable was replaced to address the reported complaint.Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse platform with (b)(6).

Event Description

During patient use, the autopulse platform (b)(6) keeps shutting off.The battery had to be removed and placed back in multiple times to reset the autopulse platform.Back at the station, the customer tested the autopulse platform on a manikin, and it duplicated the power issue twice.No consequences or impact to the patient.

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 17778198
• MDR Text Key: 323797185
• Report Number: 3010617000-2023-00795
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1